Mandatory product listing as proposed by Durbin bill is a mirage, Cohen asserts

Dr Pieter Cohen, MD, of the Harvard Medical School made his case in the paper published online on Wednesday by the New England Journal of Medicine. Cohen’s two coauthors are fellow Harvard Medical School faculty members Dr Jerry Avorn, MD,  and Dr Aaron S. Kesselheim, MD.

Unquantified risks of supplements

Cohen and his coauthors reiterated his oft cited refrain that dietary supplements can pose grave risks to consumers and are insufficiently regulated.  To bolster that view they cited a CDC study from 2015​​ that asserted that about 23,000 emergency room visits and 2,000 hospitalizations annually can be attributed to supplements.  Industry sources weighed in at the time that in their view, considering the millions of doses of supplements consumed each year, that this is actually indicative of the overall safety of the products.  In addition, the study was criticized for lumping various categories of OTC products, such as eye drops, within the definition of supplements.

Nevertheless, the authors operate from a viewpoint that supplements are risky, and these risks are unquantified.  This is so because FDA “doesn’t have a systematic approach for monitoring safety, nor can it track which supplements are currently being sold to consumers.”​

The Dietary Supplement Listing Act of 2022 was introduced by Senators Dick Durbin, D-IL and Mike Braun, R-IN to address this gap.  It would require manufacturers to submit the name of a new product, a list of the ingredients and any health claims for the product to FDA before putting the product on the market.  Cohen and his coauthors labeled this as a “poor start.”​

Bill would provide cover for industry, not protect consumers

The authors claimed the bill would do little to protect consumers from dangerous products.  They said that it has no mechanism by which FDA could verify  that the ingredients on the label represent what’s actually in the bottles sold to consumers. 

 They said there are numerous examples of supplements that are understrength, or which contain undeclared and possibly toxic ingredients. So taking a supplement label at face value is poor public policy.

The authors said that while the Durbin/Braun bill might give the illusion of progress in this area what it would in fact do it provide cover for the industry to continue to operate in its current fashion.

“In the mainstream media, the supplement industry is often described as operating in the 19th century, free from government oversight. It’s therefore in the industry’s interest for consumers to believe that the FDA is now overseeing its products. Listing ingredients and specious claims about a product’s benefits on the FDA’s website would implicitly give the agency’s imprimatur to dietary supplements, even though the agency would have no new powers to ensure their quality, efficacy, or safety,” ​the authors assert.

The authors advocate for a revision of the bill that would allow FDA to vet the ingredients and claims.  Only those supplement labels that pass muster would go onto the registry and, by extension, onto the market.

CRN: Pointless to advocate for ideas with no legislative future

Steve Mister, president and CEO of the Council for Responsible Nutrition, said CRN has long been an advocate for greater transparency as to what is on the market. CRN already operates the Supplement Owl label database.

 But, like other industry stakeholders, it is opposed to giving FDA pre market approval authority. That was a line drawn in the sand with the passage of DSHEA in 1994.  While the industry has gradually warmed to the idea that DSHEA could be improved with an update, there is no support for changing that particular provision. 

 Mister said a  Mandatory Product Listing of the sort proposed by Sens. Durbin and Braun could add worthwhile transparency to the marketplace. Furthermore, it is something that enough industry stakeholders might actually support.

“There is a reason why lawyers don’t do surgery,”​ Mister told NutraIngredients-USA​. “While the commentary is well meaning there is no evidence that [Cohen] understands the delicate process of producing a legislative draft.”​

“The kinds of things he is proposing are things that industry simply will not agree to.  That’s a non starter. Let’s do something that we can get passed in this political climate,”​ he said.

Source:​ New England Journal of Medicine​
doi: 10.1056/NEJMp2205675. Online ahead of print.
Institutionalizing Misinformation — The Dietary Supplement Listing Act of 2022​
Authors: Cohen P, Avorn J, Kesselheim AS